BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE IMMUNOCHEMISTRY SYSTEM

    MDR report key: 1994122 · Received February 16, 2011

    Report

    Report Number
    2050012-2011-00424
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQX
    PMA / PMN Number
    K962294
    Removal / Correction Number
    Z-2887-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, NO SAMPLE OR SYSTEM ISSUES WERE NOTED. CALIBRATION AND QC DATA WERE ACCEPTABLE. ISSUE OCCURRED WITH LOT M911529, AND WAS RESOLVED BY SWITCHING TO LOT M007630. SERVICE WAS NOT DISPATCHED SINCE THIS IS A REAGENT ISSUE. INVESTIGATION INTO ROOT CAUSE IS ON GOING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUS HIGH RHEUMATOID FACTOR (RF) RESULTS GENERATED BY THE IMMAGE IMMUNOCHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLE RESULTS ARE BETWEEN 20 AND 23 IU/ML WHILE USING LOT # M911529. THE RESULTS ARE <20 WHEN THE CUSTOMER SWITCHED TO LOT # M007630. UNKNOWN IF PATIENT TREATMENT WAS ADMINISTERED OR WITHHELD SINCE THE INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    ...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE IMMUNOCHEMISTRY SYSTEM NEPHELOMETER, FOR CLINICAL USE JQX BECKMAN COULTER INC. IMMAGE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1